510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K030053Substantially Equivalent

Jostent Selfx, Models 015Sx4406; 015Sx4408; 015Sx4410; 015Sx680; 015Sx6808; 015Sx6810

Jomed AG, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030053 is the FDA 510(k) clearance record for JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810, a class II device, cleared for Jomed AG on under FDA product code FGE (Stents, Drains And Dilators For The Biliary Ducts). FDA records list 2 510(k) clearances for Jomed AG, from to . As of , FDA records show no recalls naming K030053.

Clearance record

Decision date
Received
(98 days to decision)
Product code
FGE Stents, Drains And Dilators For The Biliary Ducts
Regulation
21 CFR 876.5010
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Jomed AG 15330 Ave. Of Science, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FGE

Trailing 12 months
10 clearances under product code FGE in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FGE, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20262
April 20262
May 20260
June 20261
July 20261
August 20260
September 20262
October 20260